JERUSALEM--(BUSINESS WIRE)--Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) today announced
that the New Drug Application (NDA) for SD-809 (deutetrabenazine) has
been accepted by the U.S. Food and Drug Administration (FDA) for the
treatment of chorea associated with Huntington disease (HD), a rare and
fatal neurodegenerative disorder caused by the progressive breakdown of
nerve cells in the brain that affects about five to seven people per
100,000 in western countries, according to the World Health Organization.

“The opportunity to bring a new treatment option to those battling the
devastating illness of Huntington disease is an important first step and
an indication of our profound commitment to improving the lives of
patients with this and other debilitating movement disorders,” said
Michael Hayden, M.D., Ph.D., President of Global R&D and Chief
Scientific Officer at Teva. “With this filing and an ongoing investment
in HD research, Teva has further established itself as a leader in the
development of treatments focusing on movement disorders.”

“Teva plans to commercialize SD-809 in the U.S. by drawing from vast
experience in facilitating therapy initiation and patient support in
other disease areas. Within Global Specialty Medicines, we have a rich
history of demonstrating our commitment to the patient and bringing
value to the neurology community,” said Rob Koremans, MD, President and
CEO of Global Specialty Medicines at Teva. “People living with
neurodegenerative disorders and those around them often need support and
services beyond medications. We intend to meet these needs with our
proven infrastructure and our focus on the patient.”

The NDA filing is based on positive results from two Phase-III studies,
FIRST-HD and ARC-HD. In the placebo-controlled, randomized FIRST-HD
study, SD-809 reduced chorea in patients with HD. Positive top-line data
from the Phase-III, open-label ARC-HD study demonstrated that patients
were able to safely convert from tetrabenazine, currently the only
approved HD treatment, to SD-809 overnight with continued control of
chorea.

SD-809 was granted Orphan Drug Designation for the treatment of HD by
the FDA in November 2014 and became part of Teva’s CNS portfolio with
the acquisition of Auspex Pharmaceuticals in May 2015.

The FDA designates orphan status to drugs and biologics that are
intended for the treatment of rare diseases affecting fewer than 200,000
people in the U.S.

About SD-809

SD-809 (deutetrabenazine) is an investigational, oral, small molecule
inhibitor of vesicular monoamine 2 transporter, or VMAT2, that is
designed to regulate the levels of a specific neurotransmitter,
dopamine, in the brain. SD-809 is being developed for the treatment of
chorea associated with Huntington disease, a neurodegenerative movement
disorder that impacts cognition, behavior, and movements. The FIRST-HD
study showed a favorable safety and tolerability profile, including low
rates of depression, somnolence, akathisia/restlessness and anxiety. The
safety and tolerability experience observed in the ARC-HD study was
consistent with the experience observed in the FIRST-HD study. The most
commonly reported adverse events in ARC-HD patients were somnolence,
fall, and nasopharyngitis.

About Huntington Disease

Huntington disease (HD) is a fatal neurodegenerative disease
characterized by uncoordinated and uncontrollable movements, cognitive
deterioration and behavioral and/or psychological problems. The classic
onset of HD symptoms typically occurs in middle age, but the disease
also manifests in children and the elderly. HD is the most common
genetic cause of abnormal involuntary writhing movements called chorea.
Disease progression is characterized by a gradual decline in motor
control, cognition and mental stability and generally results in death
within 15‐25 years of clinical diagnosis.

HD is a genetic disease, passed from parent to child through a gene
mutation. Each child of an HD parent has a 50-50 chance of inheriting
the HD gene. If a child does not inherit the HD gene, he or she will not
develop the disease and cannot pass it to subsequent generations. A
person who inherits the HD gene will sooner or later develop the
disease. According to the World Health Organization, Huntington disease
affects about five to seven people per 100,000 in Western countries.

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading
global pharmaceutical company that delivers high-quality,
patient-centric healthcare solutions to millions of patients every day.
Headquartered in Israel, Teva is the world’s largest generic medicines
producer, leveraging its portfolio of more than 1,000 molecules to
produce a wide range of generic products in nearly every therapeutic
area. In specialty medicines, Teva has a world-leading position in
innovative treatments for disorders of the central nervous system,
including pain, as well as a strong portfolio of respiratory products.
Teva integrates its generics and specialty capabilities in its global
research and development division to create new ways of addressing unmet
patient needs by combining drug development capabilities with devices,
services and technologies. Teva's net revenues in 2014 amounted to $20.3
billion. For more information, visit www.tevapharm.com.

This release contains forward-looking statements, which are based on
management’s current beliefs and expectations and involve a number of
known and unknown risks and uncertainties that could cause our future
results, performance or achievements to differ significantly from the
results, performance or achievements expressed or implied by such
forward-looking statements. Important factors that could cause or
contribute to such differences include risks relating to: our ability to
develop and commercialize additional pharmaceutical products;
competition for our innovative products, especially Copaxone®
(including competition from orally-administered alternatives, as well as
from potential purported generic equivalents)and our ability to
migrate users to our 40 mg/mL version; the possibility of material
fines, penalties and other sanctions and other adverse consequences
arising out of our ongoing FCPA investigations and related matters; our
ability to achieve expected results from the research and development
efforts invested in our pipeline of specialty and other products; our
ability to reduce operating expenses to the extent and during the
timeframe intended by our cost reduction program; our ability to
identify and successfully bid for suitable acquisition targets or
licensing opportunities, or to consummate and integrate acquisitions;
the extent to which any manufacturing or quality control problems damage
our reputation for quality production and require costly remediation;
increased government scrutiny in both the U.S. and Europe of our patent
settlement agreements; our exposure to currency fluctuations and
restrictions as well as credit risks; the effectiveness of our patents,
confidentiality agreements and other measures to protect the
intellectual property rights of our specialty medicines; the effects of
reforms in healthcare regulation and pharmaceutical pricing,
reimbursement and coverage; governmental investigations into sales and
marketing practices, particularly for our specialty pharmaceutical
products; adverse effects of political or economic instability, major
hostilities or acts of terrorism on our significant worldwide
operations; interruptions in our supply chain or problems with internal
or third-party information technology systems that adversely affect our
complex manufacturing processes; significant disruptions of our
information technology systems or breaches of our data security;
competition for our generic products, both from other pharmaceutical
companies and as a result of increased governmental pricing pressures;
competition for our specialty pharmaceutical businesses from companies
with greater resources and capabilities; the impact of continuing
consolidation of our distributors and customers; decreased opportunities
to obtain U.S. market exclusivity for significant new generic products;
potential liability in the U.S., Europe and other markets for sales of
generic products prior to a final resolution of outstanding patent
litigation; our potential exposure to product liability claims that are
not covered by insurance; any failure to recruit or retain key
personnel, or to attract additional executive and managerial talent; any
failures to comply with complex Medicare and Medicaid reporting and
payment obligations; significant impairment charges relating to
intangible assets, goodwill and property, plant and equipment; the
effects of increased leverage and our resulting reliance on access to
the capital markets; potentially significant increases in tax
liabilities; the effect on our overall effective tax rate of the
termination or expiration of governmental programs or tax benefits, or
of a change in our business; variations in patent laws that may
adversely affect our ability to manufacture our products in the most
efficient manner; environmental risks; and other factors that are
discussed in our Annual Report on Form 20-F for the year ended December
31, 2014 and in our other filings with the U.S. Securities and Exchange
Commission. Forward-looking statements speak only as of the date on
which they are made and we assume no obligation to update or revise any
forward-looking statement, whether as a result of new information,
future events or otherwise.